The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)

Organ Transplantation Clinical Trial

Official title:

The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT): Psychometric Characteristics of a New Scale for the Prediction of Post-transplant Psychosocial and Medical Outcomes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633424
• Other study ID #: CR-02
• Status: Completed
• Start date: October 2011
• Est. completion date: October 2016

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Given the extremely limited availability of donated organs, transplant candidates must be carefully evaluated and selected to ensure the success of the transplant and value of the organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well established, however, listing criteria for psychosocial risk factors (e.g., understanding of illness and transplant process, psychiatric history, support system, compliance, etc) is less standardized. The purpose of this research is to study the psychometric properties (e.g., predictive validity) of the new pre-transplant "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT) examination in patients who received heart, kidney, liver, or lung transplant and underwent the SIPAT evaluation before treatment. This new screening tool was designed to standardize the evaluation process of psychosocial risk factors and their severity, in order to enhance predictions of medical and psychosocial outcomes of patients post-transplant. If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be amenable to clinical intervention could be identified. In turn, this may assist in developing a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of minimizing preventable problems, mitigating risk, and optimizing graft survival, patient function, and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011 and underwent the SIPAT evaluation before treatment.

Exclusion Criteria:

• Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011, who did not undergo the SIPAT evaluation before treatment.

Related Conditions & MeSH terms

• Organ Transplantation

Locations

Country	Name	City	State
United States	Stanford Hospitals and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft survival		Assessed at any given time post initial transplantation (up to 15 minutes to assess)
Primary	Patient survival		Assessed at any given time post initial transplantation (up to 15 minutes to assess)